Project Sample – Gene Therapy
DavosPharma is managing a non-viral gene therapy program for a client. We are involved in performing animal bio-distribution and efficacy xenograft studies in rodents of the gene therapy modality and will most likely be managing the studies that leads up to filing an IND.
Project Sample – Integrated Discovery
DavosPharma is managing several programs from concept to filing IND through multiple partners and in various therapeutic indications (Oncology, Ocular, Neurodegenerative and other Neuronal diseases).
Because DavosPharma has access to a wide network of partners, we are able to choose which one is best for a particular function based on the partner’s expertise and the client’s specifications.
In most of these programs the medicinal chemistry, small scale synthesis, process chemistry and scale-up (non-GMP and GMP) of the small molecule is performed in one of our Indian, US FDA Inspected partner facilities.
In the oncology programs the ADME, the DMPK, and the pharmacology studies are performed at the same facility as the medicinal chemistry and small scale synthesis of hit compounds.
Formulation is performed by a US-based DavosPharma partner. The IND enabling toxicology studies are performed by another US-based partner. DavosPharma can also assist in filing for an IND and preparing for the pre-IND meetings with the FDA.
All of the various functions needed to take a concept to the clinic are “glued together” by the DavosPharma team. Our Team facilitates the seamless transfer of material from one group to another within the partner company and between partner companies in the DavosPharma network.
We thereby save our client both time and money as they advance their candidate drug to the clinic.
DavosPharma’s other programs are similarly structured. The medicinal and process chemistry are either performed in Europe, India, or the US. The scale-up non-GMP and GMP manufacturing are performed at one of our globally-based partner facilities.
The formulation and IND enabling studies are performed with a US or European partner. Here again, the DavosPharma Team provides a management structure between all of our partners and our client that ensures the successful advancement of the project.
